A Study to Evaluate the Safety and Efficacy of the QLT Proprietary Olopatadine-PPDS in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.

Phase 2

Terminated

• Conditions: Seasonal Allergic Conjunctivitis to Ragweed
• Interventions: Drug: Olopatadine

• Registration Number: NCT01287338
• Lead Sponsor: Mati Therapeutics Inc.

Brief Summary

The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-01
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• History of allergic conjunctivitis to ragweed for at least one year
• Positive skin prick test to ragweed pollen within 12 months prior to visit 1
• BCVA of at leat 20/400

Exclusion Criteria

• Structural lid abnormalities (ectropion, entropion)
• Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
• Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
• History of ophthalmic abnormality, including a history of dry eye
• Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
• History of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection
• presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease
• Currently on any chronic ocular topical medications
• Use of topical or systemic ocular medications during the study period
• History of complications, adverse events, trauma or disease in the nasolacrimal area
• History of symptomatic epiphoria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower Puncta Delivery	Olopatadine	-
Double Puncta Delivery	Olopatadine	-

Primary Outcome Measures

Name	Time	Method
Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed	4 Days
Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed	4 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms	4

Trial Locations

Locations (1)

Cetero Research; 🇨🇦 Toronto, Ontario, Canada